NICOLET ELECTROCAUTERY DETECTOR

NICOLET ELECTROCAUTERY DETECTOR is an FDA 510(k)-cleared medical device (K020955) manufactured by Nicolet Biomedical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 16, 2002. Regulation: 8.